Vice President - Biostatistics Scientific Advisory

3 days ago

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• Provide statistical consulting, strategic advice and operational execution in drug development • Offer world-class Biostatistics consulting and operational execution • Provide consulting and guidance throughout the clinical development process • Provide statistical expertise in designing clinical development programs, individual protocols, optimizing existing protocols, preparing submissions • Interact with clients and regulatory authorities, including representation at key regulatory meetings on behalf of the client • Work cross-functionally and attend internal and external meetings as a subject matter expert in Biostatistics • Travel to, attend and actively contribute / lead all kind of client meetings as appropriate • Support interventional and non-interventional studies and use of Real World Data (RWD) in the drug development process • Review and participate in writing publications • Provide strategic consulting in trial design optimization and execution, clinical program development, submission strategies and regulatory interactions • Provide technical leadership, serve as an internal consultant and advise internal team on advanced and/or innovative statistical designs, models and applications, complex statistical issues and challenges in clinical trials, and regulatory guidance • As a world-class expert in Biostatistics attract new business for Parexel • Work closely with Business Development, Medical, Solutions Consultants and other Parexel functions • Contribute to business development, e.g., by actively contributing to proposal development • Represent Parexel at client marketing and technical meetings • Participate in and contribute to project bids, including client presentations • Provide on-going support to Portfolio Management, Business Development, and Business Operations groups • Support efforts for generating business leads

Requirements

• Excellent organizational, communication, negotiation, problem-solving, analytical, and consulting skills • Technical leadership and contribute to a high performing team. • Outstanding understanding of the drug, device or diagnostic development process • Expertise in broad different therapeutic areas and indications • Excellent understanding of delivery models and issues in clinical trials and strategies to avoid them. • Thorough understanding of regulatory guidance and practices pertaining to specific indications and also to submissions and approval processes • Strategic awareness of our business environment • Knowledge of the International pharmaceutical market and the services required by sales, marketing, and operational support to achieve success. • An ability to assess situations and make and carry through difficult decisions. • Advanced ability to successfully manage a full workload across multiple-projects • Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions) • Demonstrable experience of stakeholder/relationship management with a client focused approach to work. • Advanced ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail • Advanced ability to work in a matrix environment and to value the importance of teamwork • Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook • Significant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge • Direct experience in consulting and project delivery. • Proven record and experience with development, execution, and implementation of research strategies in the pharmaceutical industry • Demonstration of successful direct interactions with relevant regulatory agencies like FDA/EMEA/PMDA or other local agencies • Experience with regulatory submissions and negotiations during the regulatory review process, including Advisory Committee preparation and participation. • Experience with conference presentation and manuscript writing